A randomized controlled trial of bacillus Calmette-Guerin and botulinum toxin-A for the treatment of refractory interstitial cystitis

Abstract

Introduction: Interstitial cystitis (IC) primarily occurs in middle-aged women, with a female to male ratio of 9:1. Currently, IC therapy is inadequate with only 2 treatments approved by the Food and Drug Administration: oral pentosan polysulphate and dimethyl sulfoxide (DMSO) bladder instillation. Several researchers have evaluated the efficacy of intravesical bacillus Calmette-Guerin (BCG) instillation for the treatment of IC with promising results. On the other hand, botulinum toxin-A (BTX-A) has gained widespread acceptance for the treatment of bladder overactivity, detrusor-sphincter dyssenergia, and IC. The present work is designated to evaluate the use of intravesical BCG instillation versus intravesical injection of BTX-A in patients with IC. Patients and methods: We randomly divided 36 patients who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) criteria for IC and reported at least moderate pain and frequency for a minimum of 6 months into 2 groups (cases 1,3,5,etc vs. cases 2,4,6,etc). The first group (Group I) received the standard 6 weeks of intravesical BCG instillations. The other subjects (Group II) received an intravesical injection of 300 units of BTX-A. The patients were followed at routine intervals with questionnaires and voiding diaries. Adverse events were closely monitored in the treatment and follow-up phases of the study. Results: During the follow-up period (23 weeks and 22 weeks, respectively), 11 of 16 (68.75%) patients in Group I and 14 of 16 (87.50%) patients in Group II continued to have an excellent response in all parameters measured. The global interstitial cystitis survey improved 71% in Group I and 92% in Group II; daily voids decreased 31% and 68%, nocturia improved 54% and 100%, pelvic pain decreased 81% and 96%, urgency decreased 71% and 100%, and dysuria decreased 82% and 92%, respectively. The patients in Group II showed a statistically significant improvement in all parameters compared to Group I. Conclusion: Although the safety profile of BCG is acceptable, its response rate for treatment of intractable IC was poorer in relation to BTX-A. On the other hand, though BTX-A has not yet been approved by the FDA, clinical trials have proved intravesical injection of BTX-A to be a safe and effective therapy for treatment of intractable IC within a 22-week follow-up period. © 2009 UroToday International Journal.